MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR

Model Number	GV974HD-BR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Vertebral Fracture (4520)
Date of Event	01/23/2022
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's wife, who stated that "he was sitting in the product with the wheel locks engaged when the cross-frame snapped causing him to abruptly collapse downward with the sides closing in on him".The end user was taken to the hospital where he was reportedly diagnosed with bruised ribs and multiple vertebrae fractures.End user died several days later.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• MDR Report Key: 16043199
• Report Number: 2438477-2022-00128
• Device Sequence Number: 6266315
• Product Code: ITJ
• UDI-Device Identifier: 00822383582245
• UDI-Public: 822383582245
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2022
• Report Date (Section F): 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: GV974HD-BR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2022
• Device Age: 5 YR
• Date Report to Manufacturer: 12/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Date Report Sent to FDA: 12/23/2022